Editors Note: The proponents of a menthol ban conveniently forget to mention a key recommendation of TPSAC namely: “ Should FDA choose to implement a ban…FDA would need to assess the potential for contraband menthol cigarettes as required by the Act.”.

Continued neglect of this key recommendation suggests that the proponents of ban realize that contraband considerations will dominate the debate since other considerations are either non-existent or mixed as outlined in the industry report on menthol.

FDA, as a matter of law, will have to address the fact that contraband cigarettes impose extremely adverse health effects on both smokers and non-smokers—the unilateral recommendation in the following article is the bow of a sinking ship.

Agency Will Not Regulate E-Cigarettes Under the Stricter Rules That Apply to Medical Products

April 27, 2011 — The FDA has decided to oversee electronic cigarettes the same way it does tobacco products. The agency will not regulate the vapor-producing devices under the stricter federal rules that apply to medical products.

Editors Note: When a US Senator states that an action to ban menthol cigarettes is based upon on the TPSAC report, he has not read the report in its entirety. The TPSAC made it clear that no action can be taken on a ban until the issue of contraband has been addressed. CRE has an Interactive Public Docket entitled Counterfeit Cigarettes: An Enforcement Forum which is dedicated to the contraband issue.

LAS VEGAS — When it comes to tobacco regulation, Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products (CTP), acknowledges that there might be discord on occasion. But as he told retailers and manufacturers at the NATO Show Thursday, communication is an important focus of the CTP, even during those times.

“We want to establish a relationship of good communication and trust,” he said. “We may not always agree on everything. But we can disagree on things, but we don’t need to be disagreeable. And we need to keep communicating with each other about how this is all going, so that we can all learn for each other.”

Bad anti-intellectual property laws by State and Federal Parliaments could require taxpayers to gift up to $3.4 billion per year in compensation to film companies and big tobacco for the loss of their trademarks”, Director of the IP and Free Trade Unit at the Institute of Public Affairs, Tim Wilson, said today.

Mr Wilson’s comments follow the release of a new IPA report, Governing in ignorance: Australian governments legislating, without understanding, intellectual property, released today for World Intellectual Property Day.

The Center for Regulatory Effectiveness has established an Interactive Public Docket dedicated exclusively to the discussion of counterfeit cigarettes. Counterfeit cigarettes play a crucial role in understanding many tobacco-related public policy issues ranging from a proposed ban on menthol flavoring to overpayment by tobacco companies under the 1998 settlement.

CRE has posted on the Counterfeit Cigarette IPD an article prepared by the Center for Public Integrity on an arbitration hearing to determine the extent of tobacco industry overpayment to states under the 1998 settlement. As the article explains, the marketshare held by counterfeit cigarettes is one of the issues being considered. The Center for Public Integrity article may be found here, http://www.thecre.com/cc/?p=134

Editor’s Note: What is the metric to be used to judge anti-smoking therapies? “Modified Risk” determinations are to apply to the entry of new tobacco products; should the metric being developed by the Institute of Medicine apply to anti-smoking therapies?

Siegel: Rest of the Story

Yesterday, I called for the removal of Chantix from the market, arguing that the black box warning was not adequate to protect the public from the severe adverse side effects that have been observed with the drug. Today, I explain why it is that the black box warning is not sufficient to protect consumers.

A study says the products are more hazardous and addictive, but a journal article says they are no worse than other cigarettes.

Menthol cigarettes have a higher risk of causing tobacco-related diseases than other cigarettes and should be pulled from shelves, according to a report by the Food and Drug Administration’s Tobacco Product Scientific Advisory Committee.

Editors Note: The above headline and the following article is published on Rest of the Story by Dr. Michael Siegle. To the extent TPSAC follows the stautory requirement contained in the Data Quality Act to base its actions on sound science, any alleged imperfections in controlling statutes are of no particular significance.

An op-ed by Dr. Alan Blum, Director of the Center for the Study of Tobacco and Society at the University of Alabama, published yesterday in the Birmingham News, sharply criticizes the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) for its failure to make a recommendation regarding FDA action on menthol cigarettes. Instead of making such a recommendation, the Committee simply concluded that banning menthol cigarettes would benefit the public’s health, but that there could also be black market consequences. The Committee thus gave no indication to the FDA of what policy action would be appropriate.

About the TPSAC’s actions, Dr. Blum writes: “Unfortunately, the committee that produced this sobering report did not translate its conclusion into a recommendation that menthol be banned. Instead, the committee fretted about a potential black market for menthol cigarettes and the possible introduction of do-it-yourself menthol cigarette kits to circumvent such a ban. But this reasoning puts the cart before the horse. In the end, the committee proved weak-willed.”…”The horrific impact menthol cigarettes have had on the African-American community warrants that all health organizations and everyone concerned about the rising cost of health care urge the FDA and Congress to add menthol to the list of far less widely consumed but already banned candy flavorings.”

Unlawful trade in cigarettes, particularly smuggling and counterfeiting, undermines the inflow of government revenues, encourages organised crime, misleads consumers with products whose quality is doubtful, and hampers efforts to prevent consumption by minors. This unfair practice stunts the growth of the brands of the British American Tobacco Group in several countries, lowering the values of investments in distribution and weakens the systems regulating the legally-established side of this industry.